NEW BRITAIN, Conn.--(BUSINESS WIRE)--Kelyniam Global, Inc. (Pinksheets: KLYG), an emerging medical device manufacturing company that recently was granted FDA 510(k) approval, announced today that it has begun commercial shipment of its Custom Skull Implants (CSI). Kelyniam CSI’s are seen by many in the medical community as a game-changer in the world of medical prosthetics.
Kelyniam Custom Skull Implants (CSI) are designed and manufactured for each individual patient to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects. Streamlined CAD/CAM design and manufacturing techniques enable Kelyniam to deliver patient specific implants to surgeons in as little as 24 hours from the receipt of an order. The ability to provide custom implants quickly and accurately can reduce the time between trauma and implantation and provides surgeons additional treatment options.
"We are very excited to have begun commercial shipment of our state-of-the-art Custom Skull Implants,” said James Ketner, president and CEO of Kelyniam. “We are confident our innovative technology, superior form, fit, and function will greatly enhance patient outcomes and empower surgeons by providing them with more and better treatment options than our competitors.”
Kelyniam uses Invibio’s PEEK-OPTIMA® for all of its custom implants. More about Kelyniam’s innovative use of PEEK-OPTIMA can be found at the following link: http://www.plasticstoday.com/articles/peek-empowers-custom-designed-skull-implants0706201101
“We initially became involved with the medical device industry back in 2008 when we were supplying Stereolithography (SLA) models to a device manufacturer,” said Ketner. “When we saw how those implants were being made, we decided that a better manufacturing process could be used to deliver a higher tolerance product and faster deliverable turnaround time. We were producing around 40 units per month when we were making the models, and if we can produce 40 units a month with our current pricing and share structure, that would result in retained earnings of approximately $.18/share. We anticipate production of more than 40 units per month by the end of 2012. We also have other products in development we believe will add additional revenues and earnings.”
The company also intends on becoming fully reporting with the Securities and Exchange Commission once earnings dictate a share price that will allow the company to move to a higher exchange such as the AMEX or NASDAQ.
About Kelyniam Global, Incorporated
Kelyniam Global (Pinksheets: KLYG), Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
Forward-Looking Statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.